Eur J Anaesthesiol 2019; 36:194–199

ORIGINAL ARTICLE

Comparison of rocuronium requirement in children with

continuous infusion versus intermittent bolus
A randomised controlled trial
Sheung-Nyoung Choi, Young-Eun Jang, Ji-Hyun Lee, Eun-Hee Kim, Jin-Tae Kim and Hee-Soo Kim
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BACKGROUND Minimising rocuronium administration dur-
ing paediatric surgery helps to reduce the incidence of
residual muscular blockade.
OBJECTIVE To determine whether intermittent bolus injec-
tion (Bolus group) or continuous infusion (group) requires
the lesser amount of rocuronium.
DESIGN A randomised, single-blind controlled trial.
SETTING A single university hospital from March to June
2017.
PATIENTS Sixty-six children undergoing general anaesthesia.
INTERVENTIONS Dose of rocuronium for maintenance of
muscle relaxation in either Bolus or continuous infusion
group. Train-of-four (TOF) count of two was maintained
during surgery. When TOF count reached three, 0.1 mg kg1
1 of rocuronium was administered in Bolus group or infused
at an increased rate of 0.1 mg kg1 h1 in continuous infu-
sion group.
MAIN OUTCOME MEASURES Primary outcome was the
dose of rocuronium given (mg kg1 min1). The recovery time
from the TOF count four to TOF 0.7 (RT0.7), and 0.9 (RT0.9)
were recorded. All adverse events were recorded up to
30 min after extubation.
RESULTS Mean (SD) rocuronium dose in the Bolus group
was 6.1 (0.9), [95% confidence interval (95% CI) 5.7 to 6.4]
mg kg1 min1 and 4.9 (1.0), (95% CI 4.6 to 5.3) mg kg1
min1 in the continuous infusion group (P ¼ 0.001). RT0.7
was 24.0 (13.7), 95% CI 19.3 to 28.7) min in the Bolus
group, and 25.7 (16.0), (95% CI 20.2 to 31.2) min in the
continuous infusion group (P ¼ 0.73). RT0.9 was 30.7 (17.1),
(95% CI 24.9 to 36.5) min in the Bolus group, and 30.0
(17.6), (95% CI 24.0 to 36.0) min in the continuous infusion
group (P ¼ 0.91). The incidence of adverse events was not
significantly different between two groups.
CONCLUSION In children undergoing general anaesthesia,
the dose of rocuronium given by continuous administration
was less than that with intermittent bolus.
TRIAL REGISTRATION ClinicalTrials.gov (identifier:
NCT03060707).
Published online 11 December 2018

Introduction
Rocuronium is a neuromuscular-blocking agent (NMBA)
widely used in anaesthesia.1 In common with other
NMBAs, overdose increases the risk of delayed sponta-
neous respiration, aspiration, atelectasis, hypoxia and also
hypoxic brain damage, and, rarely, death unless appro-
priate ventilation is achieved.2,3 Ensuring the appropriate
dose of rocuronium and monitoring of its effects are
therefore crucial for patient safety.
Intermittent bolus injection and continuous infusion are
two currently accepted methods of rocuronium adminis-
tration,4,5 but there is controversy as to which requires the
lesser amount. Several studies with drugs other than
NMBAs fail to provide consistent answers.6–9 Also, there
are no clinical trials comparing the doses of rocuronium
required in intermittent bolus injection and continuous
infusion during anaesthesia in children.

From the Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital (S-N C, Y-E J, J-H L, E-H K, J-T K, H-S K), Department of Anaesthesiology
and Pain Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea (H-S K)
Correspondence to Hee-Soo Kim, MD, PhD, Department of Anaesthesiology and Pain Medicine, College of Medicine, Seoul National University, #101 Daehak-ro,
Jongno-gu, 03080, Seoul, Republic of Korea
Tel: +82 2 2072 3659; fax: +82 2 747 5639; e-mail: dami0605@snu.ac.kr

0265-0215 Copyright ß 2018 European Society of Anaesthesiology. All rights reserved. DOI:10.1097/EJA.0000000000000934

Copyright © European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.


In this study of children, we compared the total intra-
operative dose of rocuronium required per unit body
weight per minute of anaesthesia time with two different
administration methods to determine which required the
smaller dose while still providing sufficient neuromuscu-
lar block for surgery. The primary outcome was the dose
of rocuronium given per kilogram per minute. The sec-
ondary outcomes were the recovery time from the TOF
count 4 to TOF 0.7 (RT0.7), and 0.9 (RT0.9), and the
number of surgeons’ complaints about insufficient neu-
romuscular block, the occurrence of apnoea or desatura-
tion right after extubation, and apnoea or desaturation
within 30 min after admission to the postanaesthesia care
unit (PACU).
Materials and methods
Recruitment and anaesthesia
A randomised comparison was conducted between
March 2017 and June 2017 at the Seoul National Uni-
versity Hospital (SNUH). The study was approved
by the SNUH Institutional Review Board (Ref. no
1612-136-821) and registered at ClinicalTrials.gov
(NCT03060707). Each participant was given a verbal
explanation, had the opportunity to ask questions about
study methods and purposes, and informed consent was
obtained from the participant and one parent. Verbal
consent was taken from participants aged under 7 years
and written consent from participants between 7 and
12 years of age. All procedures followed the principles
of Declaration of Helsinki and its subsequent revisions,
Good Clinical Practice guidelines and regulatory recom-
mendations from the Korean Ministry of Food and
Drug Safety.
The study included children of 12 years of age or less and
classified as American Society of Anaesthesiologists
(ASA) physical status I to II, who were scheduled to
undergo surgery with general anaesthesia and neuromus-
cular blockade, and whose estimated anaesthesia time
was 2 to 5 h. Exclusion criteria were as follows:
BMI  30 kg m2, previous history of hepatic failure,
renal failure, neuromuscular disease, malignant hyper-
thermia or allergy to medications administered during
general anaesthesia, peri-operative use of medications
known to interact with rocuronium (antibiotics including
aminoglycosides, lincosamide, polypeptidse, acylamino-
penicllin, the tetracycline group, metronidazole, also
phenytoin and carbamazepine, diuretics, norepinephrine,
monoamine oxidase inhibitors, calcium channel blockers,
corticosteroids and those including magnesium ion).
Patients were randomly allocated into the following two
groups using a randomisation table (online randomisation
software; http://www.randomisation.com): the intermit-
tent bolus injection group (’Bolus’ group) and continuous
infusion group (’CI’ group). Patients were enrolled by
one of the investigators. Another investigator generated
the random allocation sequence, prepared sealed opaque
Eur J Anaesthesiol 2019; 36:194–199
Copyright © European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.
Intravenous rocuronium administration in children 195
envelopes, opened the envelope immediately before the
start of the anaesthesia and assigned participants to their
respective study group. All persons in the operating room,
including patients and members of the surgical team, but
not the attending anaesthetist and/or nurse, were blind to
the method of administration.
All children complied with preoperative fasting times
according to the ASA practice guidelines.10 Anaesthesia
was induced using intravenous atropine (0.2 mg kg1)
followed by thiopental sodium (5 mg kg1) or propofol
(2 to 2.5 mg kg1). Peripheral pulse oximetry (SpO2),
noninvasive blood pressure at 1 min intervals, and
ECG devices were attached. Patients were manually
ventilated with 8 vol% of sevoflurane and 100% of oxy-
gen. After confirming that there was loss of eyelid reflex
or no response to voice, 0.6 mg kg1 rocuronium was
administered intravenously and the trachea was intu-
bated. Anaesthesia was maintained using 1 MAC (mini-
mal alveolar concentration) of sevoflurane with a
remifentanil infusion, and the FIO2 of inhaled gas was
maintained at 40%. Minute ventilation was adjusted to
maintain the partial pressure of end-tidal carbon dioxide
(ETCO2) between 35 and 40 mmHg. An oesophageal
temperature probe was inserted immediately after intu-
bation. To maintain a core temperature of at least 358C,
the Mallinckrodt Warm Touch 5200 (Soma Technology,
Inc., Bloomfield, Connecticut, USA) was used to heat
the upper portion of the body, while further heat loss
was prevented by placing the Blanketrol II (Cincinnati
Sub-Zero, Mosteller, Cincinnati, USA), a heated blanket,
under the child.
Monitoring neuromuscular blockade
After loss of consciousness but before administration of
rocuronium, the Datex-Ohmeda E-NMT ElectroSensor
(GE Healthcare, Chicago, Illinois, USA) was attached to
monitor muscle twitch. The five electrodes were placed
according to the manufacturer’s recommendations.11 The
E-NMT module automatically determined the current
level sufficient for supramaximal nerve stimulation. For
stability of the signal, train-of-four (TOF) stimulation
with supramaximal current was delivered and 0.6 mg kg1
rocuronium was administered when the twitch height
was at  95% for at least 2 min.12 A TOF count of zero
was achieved within 2 min after the administration of
0.6 mg kg1 rocuronium, indicating suitability for intuba-
tion. TOF stimulation (2 Hz) was repeated every 15 s.
As maintaining a TOF count of two is known to provide
adequate surgical working conditions without increasing
postoperative pulmonary risk, this was the target level of
muscular relaxation in both groups.13 In the Bolus group,
to achieve a TOF count of two, 0.1 mg kg1 rocuronium
was injected intravenously whenever a TOF count rose
to three, or when the surgeon complained about insuffi-
cient muscular relaxation. In the continuous infusion
group, rocuronium infusion started with a dose of
 196 Choi et al.
0.3 mg kg1 h1 when a TOF count of three was detected
for the first time. The infusion rate was adjusted by the
attending anaesthesiologists to maintain a TOF count of
two. Rocuronium administration ceased when the
remaining surgery was expected to finish within 1 h. This
was dependent on the experience of the operating team.
The administration of sevoflurane and remifentanil was
stopped immediately following the completion of surgery.
When the TOF count reached 4, atropine (0.02 mg kg1)
and neostigmine (0.03 mg kg1) were injected intrave-
nously.14,15 Children were extubated when their TOF
ratio reached 0.9, and at least one of the following criteria
was satisfied: maintaining adequate, nonparadoxical
breathing; generating a negative inspiratory pressure more
than 30 cmH2O; sustaining hip flexion with leg elevation
for 10 s or lifting the head or coughing forcefully.16 Patients
were transferred to the postanaesthesia care unit (PACU)
immediately after extubation. TOF was monitored until
the TOF ratio reached 0.9, and the times from adminis-
tration of neostigmine (TOF count of four) and the
moment of TOF ratio 0.7, and 0.9 were recorded.17 We
defined the recovery time as the time from the TOF count
4 (i.e. the atropine and neostigmine administration time) to
TOF ratio 0.7 (RT0.7) and 0.9 (RT0.9).
All adverse events were recorded, including the surgeon’s
complaints about insufficient muscle relaxation and
apnoea and/or desaturation events observed immediately
after extubation or within 30 min after admission to the
PACU. As there is no accepted definition of apnoea in
children, we used the definition of apnoea in neonates
and infants given by the American Academy of Pediatrics:
‘an unexplained episode of cessation of breathing for 20 s
or longer, or a shorter respiratory pause associated with
bradycardia, cyanosis, pallor, and/or marked hypotonia’.18
Desaturation was defined as SpO2 less than 93%.19
Sample size estimation
Information from 16 children who matched the inclusion
criteria and had undergone elective surgery was col-
lected. The method of rocuronium administration,
patient weight, anaesthesia time and the total dose of
rocuronium were reviewed. When injected intermittently
the average requirement for rocuronium divided by
patient weight and anaesthesia time was 5.8 (0.6)
mg kg1 min1. After continuous infusion, the average
was 4.8 (1.4) mg kg1 min1. The effect size was 0.96.
With the probability of a type I error (a) being 0.05 and
type II error (b) being 0.05, and a statistical power of 95%,
a total of 31 patients were required in each group.
Assuming a possibility of 10% loss of cases, we planned
to recruit 35 patients per group.
Statistical analysis
All statistical analyses were performed using SPSS 18.0
for Windows (SPSS Inc., Chicago, Illinois, USA). The
normal distribution of continuous data was first evaluated
Eur J Anaesthesiol 2019; 36:194–199
Copyright © European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.
using the Kolmogorov–Smirnov test. All continuous vari-
ables collected in our study were proven to fit normal
distribution and were analysed using the Student’s t test.
The categorical variables were analysed using the Pear-
son x2 test (or Fisher’s exact test if expected count less
than five). Data were presented as mean (SD) or 95%
confidential interval. A P value less than 0.05 was con-
sidered statistically significant.
Results
Ninety-four children were assessed for eligibility, and 24
were excluded (Fig. 1). The remaining 70 were randomly
assigned into two groups (n ¼ 35 each). Among them, two
from each group (n ¼ 4) were also excluded immediately
before to surgery because the surgical team required
intravenous metronidazole as a prophylactic antibiotic.
Therefore, 33 patients from each group completed the
trial and their results were analysed. The two groups were
comparable in terms of age, weight, height, BMI, surgical
and anaesthesia time. All personal characteristics
are summarised in Table 1 and the types of surgery in
Table 2. None of the participants showed symptoms,
signs or abnormal laboratory test results that indicated
renal or hepatic failure.
In the Bolus group, the administered dose of rocuronium
by weight and anaesthesia time was 6.1 (0.9), (95% CI 5.7
to 6.4) mg kg1 min1 and in the continuous infusion
group 4.9 (1.0), (95% CI 4.6 to 5.3) mg kg1 min1. There
was an 18% difference between the two groups that was
statistically significant (P ¼ 0.001). All children breathed
spontaneously at the end of the anaesthetic.
In the Bolus group, recovery time RT0.7 was 24.0 (13.7),
(95% CI 19.3 to 28.7) min, and in the continuous infusion
group 25.7 (16.0), (95% CI 20.2 to 31.2) min (P ¼ 0.73).
RT0.9 was 30.7 (17.1), (95% CI 24.9 to 36.5) min in the
Bolus group, and 30.0 (17.6), (95% CI 24.0 to 36.0) min
in the CI group (P ¼ 0.91). There was no significant
difference in the recovery time between the two groups
(Table 3).
Adverse events, including surgeon’s complaints about
insufficient muscle relaxation, apnoea and desaturation
(SpO2 < 93%) immediately after extubation and within
30 min of extubation are summarised in Table 4. Even
though the incidences of desaturation immediately after
and within 30 min of extubation were both slightly more
frequent in the Bolus group, these differences were of
no statistical significance. All events of desaturation
were resolved using the jaw-thrust manoeuvre and sup-
plementary oxygen.
Discussion
Our study has shown that in children, to maintain a TOF
count of two during surgery, a continuous infusion of
rocuronium requires less rocuronium per unit weight and
anaesthesia time than intermittent bolus injection.
 Intravenous rocuronium administration in children 197

Fig. 1

Enrollment
Assessed for eligibility (n = 94)

Excluded (n = 24)
.. Refused to participate (n = 18)
.. Acute kidney injury suspected (n = 4)
.. Anticonvulsant administered due to newly
developed seizure (n = 2)

Randomised (n=70)

Allocation

Allocated to intervention (n = 35) Allocated to intervention (n = 35)

.. Received allocated intervention (n = 33) .. Received allocated intervention (n = 33)
.. Did not receive allocated intervention, due to pre- .. Did not receive allocated intervention, due to pre-
operative metronidazole use (n = 2) operative metronidazole use (n = 2)

Analysis

Analysed (n = 33) Analysed (n = 33)

The CONSORT diagram.

Dong et al.,20 in a comparison of continuous infusion and
bolus injection of NMBAs, suggested that continuous
infusion of cisatracurium resulted in a significantly lower
dose than intermittent bolus injection and that the block-
ade achieved was more stable than that of intermittent
bolus injection. Our results also show that the require-
ment of rocuronium was significantly lower with contin-
uous infusion compared to intermittent bolus injection
for the same clinical effect. One possible reason why
bolus injection requires higher dose of rocuronium can be
found in the mechanism of action of nondepolarizing
NMBAs. When neuromuscular block, expressed as
depression of the single twitch height, becomes evident,
70–80% of acetylcholine receptors are occupied; to pro-
duce complete block, 92% of receptors must be
occupied.21 The margin between moderate and complete
block is narrow; once a moderate depth of neuromuscular
block has been achieved, only a small rocuronium bolus
is required for a deeper neuromuscular block than is
needed. An excessive amount of rocuronium results in
a higher concentration of plasma rocuronium, resulting
in a slower plasma concentration decay through distribu-
tion and elimination.5
As with other NMBAs, residual neuromuscular block has
been reported for rocuronium,22 and to avoid it deter-
mining the appropriate dose for adequate muscle relaxa-
tion is important. This is especially pertinent to children,
who are known to be prone to postoperative apnoea. At
particular risk are infants and neonates for whom the

Table 1 Personal characteristics of each group. Values are mean (SD) or median [IQR/range]

Bolus group CI group P

Number (male/female) 33 (18/15) 33 (17/16)
Age (years) 6.0 [4.0 to 8.5] 8.0 [4.5 to 9.0] 0.179
Height (cm) 117.0 [100.5 to 133.1] 127.1 [109.4 to 141.2] 0.118
Weight (kg) 22.8 [15.4 to 29.1] 27.8 [18.3 to 41.5] 0.131
BMI (kg m2) 16.9 [15.6 to 17.8] 17.0 [15.3 to 22.1] 0.209
Anaesthesia time (min) 185.5 (56.8) 174.7 (61.9) 0.465
Operation time (min) 141.1 (53.2) 128.8 (53.4) 0.353
Duration between cessation of rocuronium and anaesthesia end (min) 73.6 (31.4) 61.8 (30.7) 0.127

CI, continuous infusion.

Eur J Anaesthesiol 2019; 36:194–199

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 198 Choi et al.

Table 2 Surgical procedures Table 4 Adverse events

Bolus group CI group Bolus CI

Type of surgery (n U 33) (n U 33) Adverse events group (n) group (n) P
Orthopaedic surgery 19 21 Surgeons’ complaints about insufficient 4/33 3/33 1.000M
Plastic surgery 5 4 muscle relaxation
Urologic surgery 2 5 Apnoea immediately after extubation 2/33 2/33 1.000
Otorhinolaryngologic surgery 3 2 SpO2 < 93% immediately after extubation 2/33 1/33 1.000
Neurosurgery 3 0 Apnoea within 30 min of extubation 0/33 0/33 N/A
Thoracic surgery 1 1 SpO2 < 93% within 30 min of extubation 1/33 0/33 1.000

CI, continuous infusion. All P values are calculated by Fischer’s exact test. CI, continuous infusion; SpO2,
peripheral oxygen saturation.

pharmacokinetics and pharmacodynamics of rocuronium
have yet to be fully elucidated.23
As rocuronium bromide is excreted in urine and bile, it
should be used with caution in patients with clinically
significant hepatobiliary diseases, as well as chronic kid-
ney diseases.24 The same caution is also necessary in
dealing with patients with neuromuscular diseases, such
as myasthenia gravis or Lambert–Eaton myasthenic syn-
drome, which increases sensitivity to rocuronium.25 Here,
further studies are required to confirm which method of
administration provides stable neuromuscular blockade
at a lower dose.
We planned to stop the administration of rocuronium 1 h
before the end of the surgery to minimise the possibility
of residual neuromuscular block. The criterion ‘one hour’
was chosen because the previous study had shown that
after stopping the infusion, the time from TOF count of
one to TOF ratio of 0.7 was only 36 min.5 Considering
that our participants underwent surgery with a target
TOF count of two, 60 min without further rocuronium
administration should have been sufficient to prevent
residual neuromuscular block. In our study, the actual
time intervals between stopping rocuronium administra-
tion and the moment of extubation were 73.6 (31.4) min
in the Bolus group and 61.8 (30.7) min in the continuous
infusion group. Allowing 1 h proved to be sufficient to
prevent residual neuromuscular block as there were no
instances of apnoea within 30 min of extubation, and only
one out of 66 participants experienced SpO2 less than
93%. Stopping rocuronium 1 h before the end of the
surgery was not only a safety measure but also a potential
bias in our study, as predicting the end of the surgery is
heavily dependent on the attending anaesthesiologist’s
experience. Rocuronium may have been stopped too
early or too late especially when the surgical procedure
was too complex for an accurate prediction. To reduce
Table 3 Recovery times from TOF count of 4 to TOF ratio 0.7,
and 0.9
Groups Case (n) RT0.7 (min) RT0.9 (min)
Bolus group 33 24.0 (13.7) 30.7 (17.1)
CI group 33 25.7 (16.0) 30.0 (17.6)
Data are shown as mean ( SD). CI, continuous infusion; RT0.7, recovery time
from TOF count of 4 to TOF ratio 0.7; RT0.9, recovery time from TOF count of 4 to
TOF ratio 0.9.
this bias and ensure participant safety at the same time,
we could have used sugammadex instead of neostigmine.
However, its safety and efficacy has yet to be established
in children  17 years of age and thus, we did not use it in
our study.
Miller et al.26 reported that the accumulation of rocur-
onium during continuous infusion does not achieve the
clinical range required for neuromuscular blockade. In
our study, the recovery time from administration of
neostigmine (TOF count of four) to TOF ratio of 0.7
and 0.9 did not show a statistical difference between the
groups, which is in agreement with McCoy et al.5 More-
over, if we calculate the period between cessation of
rocuronium and extubation, the time was shorter in the
continuous infusion group, 61.8 (30.7) min compared with
the Bolus group 73.6 (31.4) min. It seems that continuous
infusion of rocuronium does not necessarily increase the
risk of residual neuromuscular block when compared
with that of intermittent bolus injection.
There was a heterogeneity in the distribution of the types
of surgery. There were more neurosurgical procedures in
the Bolus group than in the continuous infusion group,
but the difference was not statistically different. How-
ever, the TOF count of two was mostly satisfactory for
surgeons, regardless of the type of surgery, and as a result,
additional rocuronium given due to the dissatisfaction of
the surgeon was very rare.
The children from whom we had collected data regarding
rocuronium administration for sample size estimation had
both acceleromyographic (AMG) and electromyographic
(EMG) monitoring. AMG was recorded by TOF Watch-
SX (Organon Ltd., Dublin, Ireland), and EMG was
recorded with the same device used in our main study
(E-NMT ElectroSensor). What we learned from this
experience was that the acceleration transducer, a
square-shaped device, which detects slight movement
of the adductor pollicis muscle, is an awkward fix on small
hands and, as a result, is prone to show unreliable results.
P In contrast, the EMG sensors were relatively easier and
0.73 more reliable to fix on children. Good clinical research
0.91 practice in pharmacodynamic studies of NMBAs also
recommends both EMG and AMG as preferred standards
for phase III, IV or other clinical studies, and especially
highlights EMG as a convenient measure for small

Eur J Anaesthesiol 2019; 36:194–199

Copyright © European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.

children.12 Therefore, we used EMG monitoring to mea-
sure depth of neuromuscular block.
There were several limitations to this study. First, we
included patients with anaesthesia times between 2 and
5 h. Therefore, we could not confirm the superiority of the
continuous infusion of rocuronium in procedures less than
2 h. However, considering the simplicity of procedures that
are less than 2 h, a single bolus administration of rocur-
onium might suffice and continuous infusions are generally
not used for short procedures. Second, anaesthetists and
nurses were not blinded in our study, and this could be a
potential source of bias. Lastly, we did not compare the
lengths of the hospital stay and ICU stay and we did not
collect long-term follow-up data from the patients.
In conclusion, our study showed that in children who were
anaesthetised with sevoflurane, the dose of rocuronium
needed to maintain comparable muscle relaxation in con-
tinuous infusion was less than that of repetitive bolus
injection. In addition, there were no serious adverse events
in the PACU with either methods of administration.
Acknowledgements relating to this article
Assistance with the study: none.
Financial support and sponsorship: none
Conflicts of interest: none.
Presentation: none.
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